Safety and Efficacy of UC-MSCs in Patients With Psoriasis Vulgaris

July 3, 2015 updated by: Affiliated Hospital to Academy of Military Medical Sciences

A Study to Assess Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) in Patients With Psoriasis Vulgaris

The purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in the baseline and after MSCs infusions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Psoriasis is considered as an incurable immune-mediated inflammatory skin disease. The widely used treatments include topical agents, systemic medications and biologic agents, but all of them have some drawbacks or limitations. Besides, non-standardized treatment or the disease itself may lead transformation to other diseases, which add more importance to finding improved management strategies.

Mesenchymal stem cells (MSCs) are a heterogeneous population of cells that can differentiate into bone, cartilage and fat cells. They have several functions, such as migration to skin lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. It reported MSCs have already been used in some kinds of autoimmune disease, such as systemic lupus erythematosus (SLE), systemic sclerosis, crohn disease, rheumatoid arthritis et al.

In this study, consenting umbilical cords are donated by healthy donors. After several processing steps, UC-MSCs are separated and froze for future infusions. When volunteers are recruited, their condition will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Then MSCs will be infused according to a standard scheme. After all 6 infusions, the patient will be re-assessed by the PASI and DLQI and will be followed up for one year.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • Affiliated Hospital to Academy of Military Medical Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of stable psoriasis vulgaris for at least 6 months
  • Baseline Psoriasis Area and Severity Index (PASI) score >= 8
  • Despite systemic or topical treatment, psoriasis is still in active or recurrent condition
  • No other psoriasis management (topical or systemic) during the UC-MSCs infusions
  • Willing and able to comply with all study requirements and provide informed consent

Exclusion Criteria:

  • Other types of psoriasis, such as pustular psoriasis, psoriatic arthritis
  • With other disease
  • Systemic treatments within 4 weeks before the baseline visit
  • Topical treatment within 2 weeks before the baseline visit
  • Uncontrolled active infections
  • Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
  • History of severe systemic disease or malignancy
  • Pregnant or lactating females, or willing to have a baby in the next year
  • Cannot be traced on time
  • Any other situations not suitable for this study determined by the investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treat Psoriasis Vulgaris with UC-MSCs
Subjects in this arm will receive 6 times UC-MSCs infusions (each time 1×10^6/kg) within 8 weeks.
Biological: UC-MSCs
Psoriasis Vulgaris patients will receive 6 times UC-MSCs infusions (each time 1×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks, then the last two times will be given once every two weeks.
Other Names:
  • umbilical cord derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks
Time Frame: baseline and 8 weeks
PASI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
baseline and 8 weeks
Change from Baseline in Dermatology Life Quality Index (DLQI) score at 8 weeks
Time Frame: baseline and 8 weeks
DLQI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body temperature will be monitored for any possible infusion-related toxicities.
Time Frame: up to 3 months
up to 3 months
blood pressure will be monitored for any possible infusion-related toxicities.
Time Frame: up to 3 months
up to 3 months
Psoriasis Area and Severity Index (PASI) score
Time Frame: month 6, 9, and 12
PASI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.
month 6, 9, and 12
Dermatology Life Quality Index (DLQI) score
Time Frame: month 6, 9, and 12
DLQI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.
month 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Chen Hu, Ph.D, Affiliated Hospital to Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 3, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 3, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-PV-MSC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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